Quality Control Specialist III

Role Summary

Quality Control Specialist III at Takeda (Los Angeles). Serves as the primary LIMS subject matter expert (SME) for the site, designing, configuring, and optimizing LIMS and related digital solutions to drive compliant, paperless, and efficient QC laboratory operations. Leads end-to-end implementation of system changes and supports complex QC projects, leveraging LabWare expertise, data analytics, and digital tools to enhance data integrity and operational excellence.

Responsibilities

• Lead the transformation of QC laboratory operations through design, configuration, and enhancement of LIMS and related QC informatics platforms.
• Apply AGILE methodologies to plan, prioritize, and manage LIMS system changes and releases.
• Serve as the primary system owner for QC LabWare LIMS, focusing on configuration, lifecycle management, data integrity, and alignment to business processes.
• Maintain deep expertise in LabWare setup, including master data structures, workflows, templates, calculations, and interface design.
• Execute full lifecycle implementation of LabWare changes‚Äîrequirements, design, configuration, testing, validation, and deployment.
• Evaluate and implement LIMS functionalities and integrations that streamline QC workflows and reduce manual effort.
• Act as SME for QC systems such as LabWare, MODA, and associated digital interfaces to support system design decisions and user story development.
• Customize and optimize LIMS workflows and user interfaces to enable accurate data capture and standardized testing.
• Maximize use of LIMS and connected tools (e.g., EM, LES, equipment interfaces) to enhance performance and data integrity.
• Support data science and analytics projects through high-quality, structured data extraction from LIMS and QC systems.
• Assist with creation of analytical and reporting tools to monitor QC trends, robustness, OOS/OOT rates, and turnaround time.
• Collaborate with QC, IT, Digital, Validation, Manufacturing, and Quality Systems on LIMS enhancements, integrations, and validation strategies.
• Participate in global and local informatics forums to support harmonization of QC processes and data structures.

Qualifications

• Required: Bachelor‚Äôs degree in science, engineering, or another technical field.
• Required: 3+ years of related experience.
• Required: Strong understanding of QC operations, GxP, and data integrity principles.
• Required: Demonstrated hands-on proficiency in LabWare LIMS, including configuration, master data management, workflow design, and system optimization.
• Required: Experience supporting change control, validation, and LIMS lifecycle management.
• Required: Ability to design and implement paperless digital solutions within QC environments.
• Required: Strong analytical background, with experience using QC/LIMS data to support decision-making.
• Required: Ability to manage multiple system changes and projects while maintaining compliance and quality standards.
• Required: Strong communication, collaboration, and stakeholder-influencing skills.
• Required: Experience working in AGILE or hybrid project environments.

Skills

• LabWare LIMS proficiency (design, configuration, lifecycle management).
• QC data analytics and data integrity principles.
• AGILE project management and collaboration across functions.
• Digital QC tools integration (e.g., EM, LES, MODA integrations).
• Strong stakeholder management and effective communication.

Education

• Required: Bachelor‚Äôs degree in science, engineering, or related technical field.
• Preferred: Bachelor‚Äôs or Master‚Äôs degree in Life Sciences, Engineering, Computer Science, or related field.

Additional Requirements

• Work in a controlled environment requiring gowning and protective clothing; may involve cold, wet environments and exposure to chemicals; ability to lift up to 15 lbs; ability to work multiple shifts including weekends as necessary.